*** CHEMICAL IDENTIFICATION *** RTECS NUMBER : NI2200000 CHEMICAL NAME : Imferon CAS REGISTRY NUMBER : 9004-66-4 OTHER CAS REGISTRY NOS. : 8050-93-9 53858-58-5 LAST UPDATED : 199806 DATA ITEMS CITED : 35 COMPOUND DESCRIPTOR : Tumorigen Drug Reproductive Effector Human SYNONYMS/TRADE NAMES : * A 100 * A 100 (Pharmaceutical) * B 75 * Chinofer * Dextran iron complex * Dextrofer 75 * Eisendextran * Fe-Dextran * Fenate * Ferdex 100 * Ferric dextran * Ferridextran * Ferrodextran * Ferroglucin * Ferroglukin 75 * Imposil * Iro-Jex * Iron dextran * Iron-dextran complex * Iron dextran injection * Iron hydrogenated dextran * Ironorm injection * Myofer 100 * Polyfer * Prolongal * RCRA waste number U139 * Ursoferran *** HEALTH HAZARD DATA *** ** ACUTE TOXICITY DATA ** TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 3 gm(Fe)/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year: 18,185,1971 TYPE OF TEST : LDLo - Lowest published lethal dose ROUTE OF EXPOSURE : Intramuscular SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 1617 mg(Fe)/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : ACVTA8 Acta Veterinaria (Belgrade). (Jugoslovenska Knjiga, POB 36, YU-11001, Belgrade, Yugoslavia) V.1- 1951- Volume(issue)/page/year: 29,21,1979 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 1 gm(Fe)/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : BJPCAL British Journal of Pharmacology and Chemotherapy. (London, UK) V.1-33, 1946-68. For publisher information, see BJPCBM. Volume(issue)/page/year: 24,352,1965 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Intravenous SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 460 mg(Fe)/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : APPHAX Acta Poloniae Pharmaceutica. For English translation, see APPFAR. (Ars Polona, POB 1001, 00-680 Warsaw 1, Poland) V.1- 1937- Volume(issue)/page/year: 18,149,1961 TYPE OF TEST : LD - Lethal dose ROUTE OF EXPOSURE : Intramuscular SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : >450 mg(Fe)/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : BJPCAL British Journal of Pharmacology and Chemotherapy. (London, UK) V.1-33, 1946-68. For publisher information, see BJPCBM. Volume(issue)/page/year: 10,375,1955 TYPE OF TEST : LDLo - Lowest published lethal dose ROUTE OF EXPOSURE : Intravenous SPECIES OBSERVED : Rodent - rabbit DOSE/DURATION : 500 mg(Fe)/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : BJPCAL British Journal of Pharmacology and Chemotherapy. (London, UK) V.1-33, 1946-68. For publisher information, see BJPCBM. Volume(issue)/page/year: 10,375,1955 TYPE OF TEST : LD - Lethal dose ROUTE OF EXPOSURE : Intramuscular SPECIES OBSERVED : Rodent - rabbit DOSE/DURATION : >690 mg(Fe)/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : BJPCAL British Journal of Pharmacology and Chemotherapy. (London, UK) V.1-33, 1946-68. For publisher information, see BJPCBM. Volume(issue)/page/year: 10,375,1955 ** OTHER MULTIPLE DOSE TOXICITY DATA ** TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 700 mg/kg/7D-I TOXIC EFFECTS : Cardiac - other changes Liver - other changes Biochemical - Enzyme inhibition, induction, or change in blood or tissue levels - other oxidoreductases REFERENCE : JTEHD6 Journal of Toxicology and Environmental Health. (Hemisphere Pub., 1025 Vermont Ave., NW, Washington, DC 20005) V.1- 1975/76- Volume(issue)/page/year: 51,235,1997 ** TUMORIGENIC DATA ** TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Intramuscular SPECIES OBSERVED : Human - woman DOSE/DURATION : 20 mg/kg/3Y-I TOXIC EFFECTS : Tumorigenic - neoplastic by RTECS criteria Tumorigenic - tumors at site of application REFERENCE : BMJOAE British Medical Journal. (British Medical Assoc., BMA House, Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year: 2,277,1973 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 750 mg(Fe)/kg/4W-I TOXIC EFFECTS : Tumorigenic - Carcinogenic by RTECS criteria Tumorigenic - tumors at site of application REFERENCE : IJCNAW International Journal of Cancer. (International Union Against Cancer, 3 rue du Conseil- General, 1205 Geneva, Switzerland) V.1- 1966- Volume(issue)/page/year: 2,370,1967 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Intramuscular SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 1150 mg/kg/17W-I TOXIC EFFECTS : Tumorigenic - neoplastic by RTECS criteria Tumorigenic - tumors at site of application REFERENCE : BJCAAI British Journal of Cancer. (Macmillan Press Ltd., Houndmills, Basingstoke, Hants. RG21 2XS, UK) V.1- 1947- Volume(issue)/page/year: 15,838,1961 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 2300 mg/kg/I TOXIC EFFECTS : Tumorigenic - equivocal tumorigenic agent by RTECS criteria Blood - lymphoma, including Hodgkin's disease Tumorigenic - tumors at site of application REFERENCE : BECCAN Annual Report--Cancer Research Campaign. (Cancer Research Campaign, 2 Carlton House Terrace, London SW1Y 5AR, UK) V.1- 1924- Volume(issue)/page/year: 40,30,1962 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Intramuscular SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 2 gm(Fe)/kg/9W-I TOXIC EFFECTS : Tumorigenic - equivocal tumorigenic agent by RTECS criteria Tumorigenic - tumors at site of application REFERENCE : BJCAAI British Journal of Cancer. (Macmillan Press Ltd., Houndmills, Basingstoke, Hants. RG21 2XS, UK) V.1- 1947- Volume(issue)/page/year: 21,448,1967 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Intramuscular SPECIES OBSERVED : Rodent - rabbit DOSE/DURATION : 28 gm/kg/27W-I TOXIC EFFECTS : Tumorigenic - equivocal tumorigenic agent by RTECS criteria Tumorigenic - tumors at site of application REFERENCE : BMJOAE British Medical Journal. (British Medical Assoc., BMA House, Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year: 1,1593,1964 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - hamster DOSE/DURATION : 40 gm/kg/10W-I TOXIC EFFECTS : Tumorigenic - equivocal tumorigenic agent by RTECS criteria Liver - tumors REFERENCE : JNCIAM Journal of the National Cancer Institute. (Washington, DC) V.1-60, 1940-78. For publisher information, see JJIND8. Volume(issue)/page/year: 24,109,1960 TYPE OF TEST : TD - Toxic dose (other than lowest) ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 1120 mg(Fe)/kg/28W-I TOXIC EFFECTS : Tumorigenic - equivocal tumorigenic agent by RTECS criteria Tumorigenic - tumors at site of application REFERENCE : BMJOAE British Medical Journal. (British Medical Assoc., BMA House, Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year: 1,1800,1962 TYPE OF TEST : TD - Toxic dose (other than lowest) ROUTE OF EXPOSURE : Intramuscular SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 3760 mg(Fe)/kg/47W-I TOXIC EFFECTS : Tumorigenic - neoplastic by RTECS criteria Tumorigenic - tumors at site of application REFERENCE : BMJOAE British Medical Journal. (British Medical Assoc., BMA House, Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year: 1,947,1959 TYPE OF TEST : TD - Toxic dose (other than lowest) ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 104 gm/kg/26W-I TOXIC EFFECTS : Tumorigenic - equivocal tumorigenic agent by RTECS criteria Tumorigenic - tumors at site of application REFERENCE : JNCIAM Journal of the National Cancer Institute. (Washington, DC) V.1-60, 1940-78. For publisher information, see JJIND8. Volume(issue)/page/year: 24,109,1960 TYPE OF TEST : TD - Toxic dose (other than lowest) ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 1500 mg(Fe)/kg/8W-I TOXIC EFFECTS : Tumorigenic - Carcinogenic by RTECS criteria Tumorigenic - tumors at site of application REFERENCE : IJCNAW International Journal of Cancer. (International Union Against Cancer, 3 rue du Conseil- General, 1205 Geneva, Switzerland) V.1- 1966- Volume(issue)/page/year: 2,370,1967 TYPE OF TEST : TD - Toxic dose (other than lowest) ROUTE OF EXPOSURE : Intramuscular SPECIES OBSERVED : Human - woman DOSE/DURATION : 52 mg(Fe)/kg/6W-I TOXIC EFFECTS : Tumorigenic - Carcinogenic by RTECS criteria Tumorigenic - tumors at site of application REFERENCE : BMJOAE British Medical Journal. (British Medical Assoc., BMA House, Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year: 1,1411,1960 TYPE OF TEST : TD - Toxic dose (other than lowest) ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 2400 mg(Fe)/kg/24W-I TOXIC EFFECTS : Tumorigenic - Carcinogenic by RTECS criteria Tumorigenic - tumors at site of application REFERENCE : BJCAAI British Journal of Cancer. (Macmillan Press Ltd., Houndmills, Basingstoke, Hants. RG21 2XS, UK) V.1- 1947- Volume(issue)/page/year: 18,801,1964 TYPE OF TEST : TD - Toxic dose (other than lowest) ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 104 gm/kg/13W-I TOXIC EFFECTS : Tumorigenic - equivocal tumorigenic agent by RTECS criteria Lungs, Thorax, or Respiration - bronchiogenic carcinoma Tumorigenic - tumors at site of application REFERENCE : JNCIAM Journal of the National Cancer Institute. (Washington, DC) V.1-60, 1940-78. For publisher information, see JJIND8. Volume(issue)/page/year: 24,109,1960 ** REPRODUCTIVE DATA ** TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Intravenous SPECIES OBSERVED : Rodent - rat DOSE : 2580 gm/kg SEX/DURATION : female 17-20 day(s) after conception TOXIC EFFECTS : Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight gain) REFERENCE : TXCYAC Toxicology. (Elsevier Scientific Pub. Ireland, Ltd., POB 85, Limerick, Ireland) V.1- 1973- Volume(issue)/page/year: 5,147,1975 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Intramuscular SPECIES OBSERVED : Rodent - rat DOSE : 240 mg/kg SEX/DURATION : female 6 week(s) pre-mating TOXIC EFFECTS : Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight gain) Reproductive - Effects on Newborn - behavioral REFERENCE : BPNSBY Bulletin of the Psychonomic Society. (Psychonomic Soc., 2904 Guadalupe St., Austin, TX 78705) V.1- 1973- Volume(issue)/page/year: 10,49,1977 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Intrauterine SPECIES OBSERVED : Rodent - rat DOSE : 52500 ug/kg SEX/DURATION : female 1 day(s) pre-mating TOXIC EFFECTS : Reproductive - Maternal Effects - uterus, cervix, vagina REFERENCE : IJEBA6 Indian Journal of Experimental Biology. (Publications & Information Directorate, CSIR, Hillside Rd., New Delhi 110 012, India) V.1- 1963- Volume(issue)/page/year: 19,1124,1981 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Intramuscular SPECIES OBSERVED : Rodent - rabbit DOSE : 650 mg(Fe)/kg SEX/DURATION : female 6-18 day(s) after conception TOXIC EFFECTS : Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death, e.g., stunted fetus) REFERENCE : SJHSBD Scandinavian Journal of Haematology, Supplementum. (Munksgaard International Pub., POB 2148, DK-1016 Copenhagen K, Denmark) No.1- 1967- Volume(issue)/page/year: 32,69,1977 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Intrauterine SPECIES OBSERVED : Rodent - rat DOSE : 5250 ug/kg SEX/DURATION : female 1 day(s) pre-mating TOXIC EFFECTS : Reproductive - Maternal Effects - uterus, cervix, vagina Reproductive - Fertility - female fertility index (e.g. # females pregnant per # sperm positive females; # females pregnant per # females mated) REFERENCE : IJEBA6 Indian Journal of Experimental Biology. (Publications & Information Directorate, CSIR, Hillside Rd., New Delhi 110 012, India) V.1- 1963- Volume(issue)/page/year: 19,1124,1981 *** REVIEWS *** IARC Cancer Review:Animal Sufficient Evidence IMEMDT IARC Monographs on the Evaluation of Carcinogenic Risk of Chemicals to Man. (WHO Publications Centre USA, 49 Sheridan Ave., Albany, NY 12210) V.1- 1972- Volume(issue)/page/year: 2,161,1973 IARC Cancer Review:Human Inadequate Evidence IMEMDT IARC Monographs on the Evaluation of Carcinogenic Risk of Chemicals to Man. (WHO Publications Centre USA, 49 Sheridan Ave., Albany, NY 12210) V.1- 1972- Volume(issue)/page/year: 2,161,1973 IARC Cancer Review:Group 2B IMSUDL IARC Monographs, Supplement. (WHO Publications Centre USA, 49 Sheridan Ave., Albany, NY 12210) No.1- 1979- Volume(issue)/page/year: 7,226,1987 TOXICOLOGY REVIEW FCTXAV Food and Cosmetics Toxicology. (London, UK) V.1-19, 1963-81. For publisher information, see FCTOD7. Volume(issue)/page/year: 9,105,1971 TOXICOLOGY REVIEW BMJOAE British Medical Journal. (British Medical Assoc., BMA House, Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year: 1,683,1978 TOXICOLOGY REVIEW PEXTAR Progress in Experimental Tumor Research. (S. Karger AG, Postfach CH-4009 Basel, Switzerland) V.1- 1960- Volume(issue)/page/year: 12,102,1969 *** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA *** NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA : NOES - National Occupational Exposure Survey (1983) NOES Hazard Code - X4721 No. of Facilities: 39 (estimated) No. of Industries: 1 No. of Occupations: 2 No. of Employees: 1157 (estimated) No. of Female Employees: 573 (estimated) *** STATUS IN U.S. *** NTP 7th Annual Report on Carcinogens, 1992 : anticipated to be carcinogen *** END OF RECORD ***